Cytodyn Inc (CYDY)

[Monroe1]

10K out....better shape than ever. Incredibly written. A future great source for reference on the state of leronimab and the FDA processes. We do have a miracle drug. We do have a great team and CEO. Wow, what a great turn around year. They have accomplished a lot.
Fiscal 2024 Overview

Actions taken by the Company during fiscal 2024 included:
Hiring of Dr. Jacob Lalezari as Chief Executive Officer;
Hiring of Mitchell Cohen as interim Chief Financial Officer;
Revamping our clinical strategy to focus on oncology, inflammation, and furthering the development of a modified, longer-acting molecule, potentially for use in the HIV population among other potential applications;
Entering into several strategic partnerships with academic institutions to further the development of leronlimab on a cost-effective basis;
Resolution of our dispute with Samsung BioLogics Co., Ltd. on terms favorable to the Company;
Resolution of our dispute with Amarex Clinical Research LLC on terms favorable to the Company;
Furthering the development of a long-acting modified therapeutic; and
Closing multiple financing transactions to provide funding for the Company’s business operations and initiatives
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I expect by Halloween we should have started the trial process. Once submitted it will take the FDA 30 days to review and approve.

“We are pleased to have received the FDA’s feedback on our Phase II study of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer, and remain on track to commence our oncology trial in the coming months. Advancing leronlimab in the oncology indication has been an important priority for our team as we progress CytoDyn’s clinical pipeline,” said Dr. Jacob Lalezari, CEO